About this trial
Exercise training as part of a structured pulmonary rehabilitation program is a key factor in improving quality of life and symptoms in people with interstitial lung disease (ILD). Optimal methods of exercise training are yet to be explored in ILD. Drinking beetroot juice, which is rich in nitrate, has been shown to improve exercise performance in a variety of groups, but its effects in ILD have not been tested. The purpose of this study is to determine if drinking nitrate-rich beetroot juice can improve exercise performance compared to drinking nitrate-free beetroot juice in people with ILD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable ILD with a differential diagnosis that consists of the above diagnoses
Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis
Oxygen saturation ≥92% by pulse oximetry at rest while breathing room air
Clinically stable for the preceding 6 weeks
Disqualifiers
Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease) (see Table 4 from ERS/ATS consensus statement)
Other significant pulmonary or extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
FVC <50% or DLCO <25%
Use of prednisone >10 mg/day for >2 weeks within 3 months of the first study visit
Trial design
Crossover
Treatments tested in this trial
concentrated beetroot juice (400mg of nitrate per serving)
Dietary supplementDietary nitrate supplementation includes consumption of two beverages daily for 7 consecutive days.
concentrated beetroot juice (trace amounts of nitrate per serving)
Dietary supplementDietary placebo supplementation includes consumption of two beverages daily for 7 consecutive days.
Treatment groups
Trial outcomes
Primary outcomes
Difference in submaximal cycle exercise endurance time following dietary nitrate supplementation compared to placebo supplementation.
Exercise endurance time will be measured during submaximal constant load cycle exercise testing.
Secondary outcomes
Difference in exertional dyspnoea during submaximal cycle exercise following dietary nitrate supplementation compared to placebo supplementation.
Dyspnea rating, measured using the Borg 0-10 category ratio scale, will be assessed at rest and every 1 minute during submaximal constant load cycle exercise testing until exhaustion.
Difference in exertional dyspnoea during activities of daily living following dietary nitrate supplementation compared to placebo supplementation.
Shortness of breath during daily living patterns will be assessed using established questionnaires.
Difference in concentration of plasma nitrate ([NO3-]) and nitrite ([NO2-]) following dietary nitrate supplementation compared to placebo supplementation.
Blood samples will be taken and analyzed for the concentration levels of nitrates in blood plasma.
Difference in resting, exercise, and post-exercise blood pressure following dietary nitrate supplementation compared to placebo supplementation.
Blood pressure will be measured using a manual sphygmomanometer at rest, every 2 minutes during submaximal constant load cycle exercise testing until exhaustion, and 5 minutes after exercise ends.
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